Prostate CancerPROCOGNCT07710807
Transperineal Versus Transrectal Cognitive Fusion Prostate Biopsy
A study testing Transrectal Cognitive Fusion Prostate Biopsy and Transperineal Cognitive Fusion Prostate Biopsy in people with Prostate Cancer and Clinically Significant Prostate Cancer, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized controlled trial aims to compare transperineal and transrectal cognitive fusion prostate biopsy techniques in patients with suspicious prostate lesions detected by multiparametric magnetic resonance imaging (mpMRI). Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Clinically Significant Prostate Cancer, Cognitive Fusion
- What is being tested?
- Transrectal Cognitive Fusion Prostate Biopsy and Transperineal Cognitive Fusion Prostate Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 50-75 years.
- Patients with PI-RADS 3, 4, or 5 lesions detected on multiparametric prostate magnetic resonance imaging (mpMRI).
- Patients with an indication for prostate biopsy.
- Patients who are willing to participate and provide informed consent.
Who cannot join
- Previous diagnosis of prostate cancer.
- Active urinary tract infection.
- Coagulopathy or bleeding disorders preventing prostate biopsy.
- Absence of multiparametric prostate MRI evaluation.
- No indication for prostate biopsy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06170
ALPER GOK, Proffessor Doctor, +90 532 603 11 81, alper_gok@hotmail.com
About this study
Official title: Comparison of Transperineal and Transrectal Cognitive Fusion Prostate Biopsy for the Detection of Clinically Significant Prostate Cancer in Patients With mpMRI-Detected Suspicious Lesions: A Prospective Randomized Controlled Trial
This prospective randomized controlled trial aims to compare transperineal and transrectal cognitive fusion prostate biopsy techniques in patients with suspicious prostate lesions detected by multiparametric magnetic resonance imaging (mpMRI).
Patients aged 50-75 years with PI-RADS 3-5 lesions on mpMRI and an indication for prostate biopsy will be randomly assigned in a 1:1 ratio to undergo either transperineal cognitive fusion prostate biopsy or transrectal cognitive fusion prostate biopsy.
Read more
The primary objective of this study is to evaluate whether transperineal cognitive fusion biopsy is non-inferior to transrectal cognitive fusion biopsy in detecting clinically significant prostate cancer (csPCa). Secondary objectives include comparison of overall prostate cancer detection rates, detection of Gleason Grade Group ≥2 prostate cancer, biopsy-related infectious complications, other procedure-related complications, pain scores, and procedure duration.
A total of 280 participants will be enrolled. Pathological evaluation will be performed after biopsy, and clinical outcomes and complications will be assessed during follow-up.
Read the detailed description
Prostate cancer is one of the most common malignancies among men. Multiparametric magnetic resonance imaging (mpMRI) has become an important tool for prostate cancer detection and risk stratification, particularly with the use of the Prostate Imaging Reporting and Data System (PI-RADS). Patients with PI-RADS 3-5 lesions are frequently considered candidates for targeted prostate biopsy.
Transrectal ultrasound-guided prostate biopsy has traditionally been the standard biopsy approach. However, the transrectal route may carry a risk of infectious complications due to passage through rectal mucosa and exposure to rectal flora. Transperineal prostate biopsy has gained increasing interest because it avoids transgression of the rectal mucosa and may reduce infectious complications.
Cognitive fusion biopsy is an MRI-targeted biopsy technique in which mpMRI findings are mentally correlated with real-time ultrasound images by the operator. This technique provides an accessible alternative to software-based fusion systems and can achieve accurate targeted sampling when performed by experienced clinicians.
The aim of this study is to prospectively compare transperineal and transrectal cognitive fusion prostate biopsy techniques regarding diagnostic performance and safety outcomes in patients with PI-RADS 3-5 lesions detected on mpMRI.
Eligible participants aged 50-75 years with biopsy indications will be randomized using a computer-generated stratified block randomization method. Randomization will be stratified according to PI-RADS category (3, 4, or 5) and age group (<60 years and ≥60 years).
Participants will undergo either transperineal or transrectal cognitive fusion prostate biopsy according to their assigned study group. Systematic biopsy cores and targeted biopsy cores will be obtained according to the institutional protocol.
The primary endpoint is the detection rate of clinically significant prostate cancer, defined as Gleason Grade Group ≥2 (ISUP Grade Group ≥2) prostate cancer. The primary analysis will evaluate non-inferiority of transperineal biopsy compared with transrectal biopsy.
Secondary endpoints include overall prostate cancer detection rate, Gleason Grade Group ≥2 cancer detection, infectious complications (fever, urinary infection, prostatitis, sepsis), procedure-related complications (hematuria, hematospermia, urinary retention), pain assessed by visual analog scale (VAS), and procedure duration.
Participants will be followed for 30 days after biopsy for assessment of adverse events and complications.
- Being tested
- Transrectal Cognitive Fusion Prostate Biopsy, Transperineal Cognitive Fusion Prostate Biopsy
- Keywords
- prostate biopsy, Transperineal biopsy, Transrectal biopsy, Multiparametric magnetic resonance imaging, Prostate cancer detection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transrectal Cognitive Fusion Prostate BiopsyProcedure or surgery
Cognitive fusion targeted prostate biopsy performed through the transrectal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.
Transperineal Cognitive Fusion Prostate BiopsyProcedure or surgery
Cognitive fusion targeted prostate biopsy performed through the transperineal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Transrectal Cognitive Fusion Prostate Biopsy | Active comparator | Participants randomized to this arm will undergo transrectal cognitive fusion targeted prostate biopsy combined with systematic prostate biopsy according to the institutional protocol. Receives: Procedure: Transrectal Cognitive Fusion Prostate Biopsy |
| Transperineal Cognitive Fusion Prostate Biopsy | Experimental | Participants randomized to this arm will undergo transperineal cognitive fusion targeted prostate biopsy combined with systematic prostate biopsy according to the institutional protocol. Receives: Procedure: Transperineal Cognitive Fusion Prostate Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant prostate cancer detection rate
Comparison of clinically significant prostate cancer (csPCa) detection rates between transperineal and transrectal cognitive fusion prostate biopsy techniques. Clinically significant prostate cancer is defined as Gleason Grade Group ≥2 (ISUP Grade Group ≥2) prostate cancer.
Measured: Within 4 weeks after biopsy (after final pathological evaluation)
Secondary outcomes (5)
Overall prostate cancer detection rate
Comparison of overall prostate cancer detection rates between transperineal and transrectal cognitive fusion prostate biopsy techniques
Measured: Within 4 weeks after biopsy (after final pathological evaluation)
Post-biopsy infectious complications
Assessment and comparison of infectious complications including fever, urinary infection, prostatitis, and sepsis after prostate biopsy.
Measured: Within 30 days after biopsy
Post-biopsy procedure-related complications
Assessment and comparison of procedure-related complications including hematuria, hematospermia, urethral bleeding, and urinary retention.
Measured: Within 30 days after biopsy
Pain score after biopsy procedure
Assessment of patient-reported pain using the Visual Analog Scale (VAS) after biopsy.
Measured: Immediately after biopsy procedure
Procedure duration
Comparison of procedure duration between transperineal and transrectal cognitive fusion prostate biopsy techniques.
Measured: During biopsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either transrectal cognitive fusion prostate biopsy or transperineal cognitive fusion prostate biopsy. Randomization will be stratified according to PI-RADS category (3, 4, or 5) and age group (\<60 or ≥60 years).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammed Yusuf Aydın, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710807
- Sponsor's protocol ID
- AEŞH-EK-2026-114
- Other IDs
- ANKARA ETLIK CITY HOSPİTAL
- Acronym
- PROCOG
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transperineal and Transrectal Cognitive Fusion Prostate Biopsy for the Detection of Clinically Significant Prostate Cancer in Patients With mpMRI-Detected Suspicious Lesions: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07710807
- Acronym / sponsor ID
- PROCOG / AEŞH-EK-2026-114
- Keywords
- prostate biopsy, Transperineal biopsy, Transrectal biopsy, Multiparametric magnetic resonance imaging, Prostate cancer detection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized controlled trial aims to compare transperineal and transrectal cognitive fusion prostate biopsy techniques in patients with suspicious prostate lesions detected by multiparametric magnetic resonance imaging (mpMRI).
Patients aged 50-75 years with PI-RADS 3-5 lesions on mpMRI and an indication for prostate biopsy will be randomly assigned in a 1:1 ratio to undergo either transperineal cognitive fusion prostate biopsy or transrectal cognitive fusion prostate biopsy.
The primary objective of this study is to evaluate whether transperineal cognitive fusion biopsy is non-inferior to transrectal cognitive fusion biopsy in detecting clinically significant prostate cancer (csPCa). Secondary objectives include comparison of overall prostate cancer detection rates, detection of Gleason Grade Group ≥2 prostate cancer, biopsy-related infectious complications, other procedure-related complications, pain scores, and procedure duration.
A total of 280 participants will be enrolled. Pathological evaluation will be performed after biopsy, and clinical outcomes and complications will be assessed during follow-up.
Detailed description
Prostate cancer is one of the most common malignancies among men. Multiparametric magnetic resonance imaging (mpMRI) has become an important tool for prostate cancer detection and risk stratification, particularly with the use of the Prostate Imaging Reporting and Data System (PI-RADS). Patients with PI-RADS 3-5 lesions are frequently considered candidates for targeted prostate biopsy.
Transrectal ultrasound-guided prostate biopsy has traditionally been the standard biopsy approach. However, the transrectal route may carry a risk of infectious complications due to passage through rectal mucosa and exposure to rectal flora. Transperineal prostate biopsy has gained increasing interest because it avoids transgression of the rectal mucosa and may reduce infectious complications.
Cognitive fusion biopsy is an MRI-targeted biopsy technique in which mpMRI findings are mentally correlated with real-time ultrasound images by the operator. This technique provides an accessible alternative to software-based fusion systems and can achieve accurate targeted sampling when performed by experienced clinicians.
The aim of this study is to prospectively compare transperineal and transrectal cognitive fusion prostate biopsy techniques regarding diagnostic performance and safety outcomes in patients with PI-RADS 3-5 lesions detected on mpMRI.
Eligible participants aged 50-75 years with biopsy indications will be randomized using a computer-generated stratified block randomization method. Randomization will be stratified according to PI-RADS category (3, 4, or 5) and age group (<60 years and ≥60 years).
Participants will undergo either transperineal or transrectal cognitive fusion prostate biopsy according to their assigned study group. Systematic biopsy cores and targeted biopsy cores will be obtained according to the institutional protocol.
The primary endpoint is the detection rate of clinically significant prostate cancer, defined as Gleason Grade Group ≥2 (ISUP Grade Group ≥2) prostate cancer. The primary analysis will evaluate non-inferiority of transperineal biopsy compared with transrectal biopsy.
Secondary endpoints include overall prostate cancer detection rate, Gleason Grade Group ≥2 cancer detection, infectious complications (fever, urinary infection, prostatitis, sepsis), procedure-related complications (hematuria, hematospermia, urinary retention), pain assessed by visual analog scale (VAS), and procedure duration.
Participants will be followed for 30 days after biopsy for assessment of adverse events and complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either transrectal cognitive fusion prostate biopsy or transperineal cognitive fusion prostate biopsy. Randomization will be stratified according to PI-RADS category (3, 4, or 5) and age group (<60 or ≥60 years).
| Arm | Type | Receives |
|---|---|---|
| Transrectal Cognitive Fusion Prostate Biopsy | Active comparator | Procedure: Transrectal Cognitive Fusion Prostate BiopsyParticipants randomized to this arm will undergo transrectal cognitive fusion targeted prostate biopsy combined with systematic prostate biopsy according to the institutional protocol. |
| Transperineal Cognitive Fusion Prostate Biopsy | Experimental | Procedure: Transperineal Cognitive Fusion Prostate BiopsyParticipants randomized to this arm will undergo transperineal cognitive fusion targeted prostate biopsy combined with systematic prostate biopsy according to the institutional protocol. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients aged 50-75 years.
- Patients with PI-RADS 3, 4, or 5 lesions detected on multiparametric prostate magnetic resonance imaging (mpMRI).
- Patients with an indication for prostate biopsy.
- Patients who are willing to participate and provide informed consent.
Key exclusion criteria (5 listed)
- Previous diagnosis of prostate cancer.
- Active urinary tract infection.
- Coagulopathy or bleeding disorders preventing prostate biopsy.
- Absence of multiparametric prostate MRI evaluation.
- No indication for prostate biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transrectal Cognitive Fusion Prostate BiopsyCognitive fusion targeted prostate biopsy performed through the transrectal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy. | Procedure or surgery | Transrectal Cognitive Fusion Prostate Biopsy |
| Transperineal Cognitive Fusion Prostate BiopsyCognitive fusion targeted prostate biopsy performed through the transperineal approach using multiparametric MRI findings for lesion targeting, combined with systematic prostate biopsy. | Procedure or surgery | Transperineal Cognitive Fusion Prostate Biopsy |
Primary outcome
Clinically significant prostate cancer detection rate
Time frame: Within 4 weeks after biopsy (after final pathological evaluation)
Comparison of clinically significant prostate cancer (csPCa) detection rates between transperineal and transrectal cognitive fusion prostate biopsy techniques. Clinically significant prostate cancer is defined as Gleason Grade Group ≥2 (ISUP Grade Group ≥2) prostate cancer.
5 secondary outcomes
Overall prostate cancer detection rate
Time frame: Within 4 weeks after biopsy (after final pathological evaluation)
Post-biopsy infectious complications
Time frame: Within 30 days after biopsy
Post-biopsy procedure-related complications
Time frame: Within 30 days after biopsy
Pain score after biopsy procedure
Time frame: Immediately after biopsy procedure
Procedure duration
Time frame: During biopsy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transrectal Cognitive Fusion Prostate Biopsy and Transperineal Cognitive Fusion Prostate Biopsy in people with Prostate Cancer and Clinically Significant Prostate Cancer, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MUHAMMED Y AYDIN, Doctor (+90 554 838 4510 ext. +90, mysfa63@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant prostate cancer detection rate (time frame: Within 4 weeks after biopsy (after final pathological evaluation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.